- ThermoFisher Scientific (Wilmington, NC)
- …of relevant experience in the pharmaceutical/biotech industry with at least 5 years in pharmacovigilance/ drug safety (global experience is a plus) + At least 1 ... Information:** Join Thermo Fisher Scientific as a Global Medical Safety Lead Physician(FSP) based in the United States and...and contribute to breakthrough solutions , the Global Medical Safety Lead could be a great fit. **Purpose of… more
- Black & Veatch (Raleigh, NC)
- …programs . Ability to write detailed reports **Certifications** First Aid, CPR, Drug testing certified, Safety and Health Program Administration, OSHA 10 ... ** Safety & Health Spec/Advisor - BESS - NC**...based in Asheville, NC. \#LI-CR1 **Key Responsibilities** + Performs drug and alcohol screens in accordance with company substance… more
- Parexel (Raleigh, NC)
- …of Medical Monitoring and study design/execution, preferred * Good knowledge of the drug development process including drug safety , preferred * Excellent ... clients in the journey of getting new and innovative drug treatments into the hands of those who need.../ Medical Director are to: * Provide medical and safety monitoring for assigned projects * Provide medical expertise… more
- Sumitomo Pharma (Raleigh, NC)
- …partners **Key Core Competencies** + Strong understanding of pharmacovigilance regulations and drug safety reporting requirements + Skills in signal detection, ... to manage the benefit/risk profile of assigned products and ensure patient safety . + Assist in signal detection activities including data assembly, signal… more
- Black & Veatch (Raleigh, NC)
- …effectively interface with client and government officials **Certifications** First Aid, CPR, Drug testing certified, OSHA 500/501, Safety and Health Program ... ** Safety & Health Manager - BESS - NC**...\#LI-CR1 **Key Responsibilities** + Implements, administers and maintains project Drug and Alcohol Substance Abuse Program. Develops and conducts… more
- United Therapeutics (Research Triangle Park, NC)
- …events (SAEs) that occur during studies as and when they are notified to Global Drug Safety to assist in identifying any emergent safety concerns that ... Medical Director - Medical Monitoring will ensure individual subject safety and the scientific integrity of studies during the...on study design, scheduled assessments, and protection of subject safety + Review and approve all versions of the… more
- Parexel (Raleigh, NC)
- …study design/execution, preferred + Clinical practice experience + Good knowledge of the drug development process including drug safety , preferred + ... therapeutic expertise and some experience across indications, clients and drug development. They initiate and maintain medical and consultative relationships… more
- Parexel (Raleigh, NC)
- …level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to ... and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good… more
- Sumitomo Pharma (Raleigh, NC)
- …authoring clinical sections for INDs, NDAs, and other related documents. + Partner with Drug Safety & Pharmacovigilance to assess the safety profile of ... monitoring overall study integrity, and review, interpretation, and communication of safety and efficacy data. + Present at scientific, medical, and regulatory… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …aggregate reports preparation, signal management and ad hoc requests. + Support drug safety systems through business administration tasks, including database ... regulatory reporting timelines. Manage project implementation and execution of safety systems, including ongoing business support and continuous improvement… more